Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis
Conditions
Interventions
Treatment arm: 5 mg of oral alendronate once daily
Control arm: Standard care only
Sponsors
Kyushu University, Department of Orthopaedic Surgery (Japan)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Female postmenopausal patients with RA who met the American College of Rheumatology diagnostic criteria for RA.
Exclusion criteria
Exclusion criteria: 1. The presence of abnormalities on spinal radiographs such as severe osteophytosis, scoliosis, spinal fusion, fracture deformation 2. Any disease known to affect bone turnover 3. Current or past glucocorticoid therapy comprising greater than 7.5 mg/day (predonisone equivalent) 4. Current or past use of anabolic steroids, calcitonin, supplemental vitamin D or vitamin K, bisphosphonate 5. Current or past hormone replacement therapy 6. Spinal areal Bone Mineral Density (BMD) T-score greater than -1.0
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Longitudinal evaluation for the following was done at baseline and at least 7 months after the baseline assessment (average follow-up was 12.15 months), and percentage change was calculated: 1. BMD assessed by Dual energy X-ray Absorptiometry (DXA) 2. Various parameters (such as bone volume fraction, vertebral compressive strength), derived from quantitative CT evaluation including finite element analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| RA disease activity was assessed by Disease Activity Score (DAS-28), at least 7 months after the baseline assessment (average follow-up was 12.15 months). | — |
Countries
Japan
Outcome results
None listed